Senior Engineer, Quality Assurance

• Lead product field action assessments from initiation through review and approval, ensuring complete, accurate, and timely documentation.
• Investigate complex product quality issues using structured problem-solving, root cause analysis, and statistical evaluation methods.
• Perform post-market health risk assessments and health hazard evaluations to assess potential product and patient safety risks.
• Develop containment recommendations and corrective actions based on investigation findings, risk assessments, and quality data.
• Author and manage nonconformance and corrective and preventive action records, including defined deliverables, action owners, timelines, and supporting documentation.
• Coordinate investigation and corrective action reviews with Research & Development, Manufacturing, Regulatory, Quality, Marketing, Service, and supplier teams.
• Represent Quality Assurance processes during internal and external audits and maintain compliance with applicable quality system, risk management, and post-market requirements.

Required Qualifications

What you will need

• Bachelor’s degree in science, engineering, or a related discipline.
• Minimum 2 years of experience in quality assurance or customer quality.
• Experience working in a regulated industry, such as medical devices or aerospace.
• Experience conducting post-market quality assessments.

Preferred Qualifications

• Master’s degree in science, engineering, or related discipline.
• Experience conducting product field actions.
• Experience working with ISO 14971, ISO 13485, 21 CFR Part 820, and European Union Medical Device Regulation requirements.
• Six Sigma Green Belt certification or experience with formal investigative techniques.

United States of America Pay Ranges

• Puerto Rico: $69,500 - $110,900 USD Annual
• USN: $77,700 - $129,500 USD Annual
• US5: $81,600 - $136,000 USD Annual
• US10: $85,500 - $142,500 USD Annual
• US15: $89,400 - $148,900 USD Annual
• US20: $93,200 - $155,400 USD Annual
• US30: $101,000 - $168,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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